Objective: To investigate the efficacy of thermocoagulation of the tibial nerve and a polypropylene ankle-foot orthosis (AFO) on spasticity of the leg in stroke patients with a spastic equinus or equinovarus foot. Design: A placebo-controlled randomized clinical trial with a 2 x 2 factorial design. Setting: Outpatient clinic, Department of Rehabilitation Medicine, Academisch Ziekenhuis Vrije Universiteit Amsterdam. Subjects: 60 stroke patients (17 women, 43 men), with a median age of 58 years and a median period of 34 months poststroke, with at least independent walking capacities at home. Main outcome measures: Change in spasticity, muscle tone, ankle clonus, Achilles tendon reflex, ankle range of motion (ROM), motor function of the leg, and balance, measured six and 15 weeks after randomization. Results: Thermocoagulation, rather than the AFO, reduced spasticity, muscle tone, Achilles tendon hyperexcitability, and ankle clonus. At six-week follow- up, the effects on Achilles tendon reflex and ankle clonus were the most pronounced; reflex excitability was reduced in 59% of the patients treated with thermocoagulation, as compared to 14% of the placebo-treated patients, whereas ankle clonus was reduced in 55% and 0% of the patients, respectively. Reduced spasticity was found in 35% of the actively treated, as compared to 10% of the placebo-treated patients. For muscle tone, the percentages of improved patients in each group were 45% and 24%, respectively. After 15 weeks the differences between the groups were smaller. No clinically relevant improvement was found with regard to ROM, the Fugl-Meyer lower extremity and balance scores, walking ability and walking speed. Conclusion: Thermocoagulation is effective for the reduction of spasticity in stroke patients with a spastic equinus or equinovarus foot. No effect on spasticity of the AFO could be demonstrated. When the efficacy of thermocoagulation and the AFO are judged in terms of functional abilities, however, the effects seem of little value.
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